| Primary Device ID | 00768455108107 |
| NIH Device Record Key | 5c151c4e-7826-461f-94bd-4856d7138388 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiPore Sponge |
| Version Model Number | 125199 |
| Catalog Number | 125199 |
| Company DUNS | 809784593 |
| Company Name | CONVATEC, PURCHASING DEPARTMENT |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00768455108107 [Primary] |
| GS1 | 10768455108104 [Package] Package: CASE [25 Units] In Commercial Distribution |
| EFQ | Gauze/Sponge, Internal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-22 |
| 10768455203946 - ESTEEM | 2024-09-23 N/A |
| 10768455209481 - ESENTA | 2024-09-03 ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR |
| 10768455209511 - ESENTA | 2024-09-03 ESENTA THIN CURVE 3X9CM (1X80PK) NAI |
| 00768455204793 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X30PK US |
| 00768455204823 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X30PK US |
| 00768455204854 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH14 1X30PK US |
| 00768455207145 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X10PK US |
| 00768455207169 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X10PK US |